• New management crew singularly centered on executing GTX-104 technique

• Introduced alignment with the U.S. Meals and Drug Administration (FDA) for Pivotal STRIVE-ON Section 3 Security Trial for GTX-104 with first affected person anticipated to be dosed previous to the top of 2023

• Money and money equivalents as of quarter finish had been $21.6 million; firm reiterates projected money runway to Q2 2025, past potential submission of GTX-104 New Drug Utility (NDA)

• Summary of pharmacokinetic comparability of GTX-104 with oral nimodipine accepted for presentation at 2023 Neurocritical Care Society (NCS) annual assembly

PRINCETON, N.J, Aug. 11, 2023 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Firm), a late-stage, biopharma firm advancing GTX-104, its novel formulation of nimodipine that addresses the excessive unmet medical wants for a uncommon illness, aneurysmal subarachnoid hemorrhage (aSAH), at present introduced monetary outcomes and enterprise highlights for the quarter ended June 30, 2023.

“Throughout our first quarter we made substantial progress executing on the strategic imaginative and prescient we specified by April, shifting with full pace to prioritize growth of GTX-104, streamline our operations, prolong our money runway to totally fund the scientific growth of GTX-104, and strengthen our management crew with business leaders in our sector,” mentioned Prashant Kohli, CEO of Acasti. “With FDA alignment of our proposed protocol and dosing routine for our pivotal Section 3 STRIVE-ON security trial (the STRIVE-ON trial) now in hand, we’re finishing our superior preparations for the trial, and plan to provoke it within the coming weeks. We count on to dose the primary affected person on this trial within the fourth quarter of this calendar 12 months and, if profitable, probably submit an NDA for GTX-104 within the first half of calendar 2025. With the efficiencies gained by way of our operational realignment, we reiterate that our projected money runway now extends to the second quarter of 2025, inclusive of the potential NDA submission. We’re excited concerning the progress we have now made and sit up for presenting the information highlighting the potential of GTX-104 on the NCS convention later subsequent week.”

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Current Company Highlights 

• Carried out strategic realignment plan that extends projected money runway by way of calendar Q2 2025

  • Prioritized sources to largest worth driver – GTX-104.

  • Vital extension of the Firm’s money runway facilitates the achievement of important worth inflection milestones, together with a possible NDA submitting for GTX-104.

  • Analysis of strategic alternate options to maximise worth of de-prioritized pipeline belongings (GTX-102 and GTX-101) together with out-licensing or sale.

• Introduced alignment with FDA on the STRIVE-ON trial protocol.

  • The STRIVE-ON trial might be a potential, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 in contrast with oral nimodipine, in sufferers hospitalized for aSAH. Key trial design options embody:

    • Roughly 100 sufferers might be enrolled at an estimated 25 hospitals within the U.S.

    • The first endpoint is security and might be measured as comparative adversarial occasions, together with hypotension, between the 2 teams.

    • GTX-104 might be administered as a steady IV infusion of 0.15 mg/hour, and a 30-minute IV bolus of 4 mg each 4 hours. Oral nimodipine might be administered as 60 mg (two 30 mg capsules) each 4 hours.

    • Each teams will obtain their assigned GTX-104 or oral nimodipine for as much as 21 consecutive days and might be evaluated from graduation of affected person remedy by way of a 90-day follow-up interval.

  • The FDA additionally supplied steerage for a possible GTX-104 NDA submission.

  • GTX-104 has been administered to over 150 wholesome topics so far and has a well- established security profile.

• Introduced choice of WuXi as CRO to conduct the STRIVE-ON trial of GTX-104 in aSAH sufferers; Acasti and WuXi proceed preparatory work prematurely of Acasti’s latest alignment with the FDA on the protocol for the STRIVE-ON trial.

• Summary of pharmacokinetic comparability of GTX-104 with oral nimodipine accepted for presentation as a poster on the 2023 Neurocritical Care Society (NCS) annual assembly.

• Enhanced senior management crew with the appointments of Dr. R. Loch Macdonald, MD, PhD, (Chief Medical Officer), Carrie D’Andrea (VP Medical Operations), and Amresh Kumar, PhD (VP Program Administration).

• Introduced enlargement of Scientific Advisory Board (SAB) to incorporate:

  • Distinguished physicians and key opinion leaders W. Taylor Kimberly, MD, PhD, Alejandro A. Rabinstein, MD and Sherry H-Y. Chou, MD

  • Acasti’s SAB now possesses scientific experience in neurosurgery and neurocritical care from main tutorial medical facilities throughout the nation.

First Quarter 2024 Monetary Outcomes

The Firm’s consolidated monetary statements have been ready in accordance with typically accepted accounting ideas in the US of America and are introduced in U.S. {dollars}. On June 29, 2023, the Board of Administrators of the Firm authorized a reverse inventory cut up of the Firm’s Class A typical shares, no par worth per share, at a ratio of 1-for-6, which was efficient on July 10, 2023. All references under to the variety of frequent shares, value per share and weighted common variety of shares excellent have been adjusted to mirror such reverse inventory cut up.

• Web loss for the three months ended June 30, 2023, was $4.0 million, or $0.54 per share in comparison with $4.5 million, or $0.61 per share, for the three months ended June 30, 2022.

• Analysis and growth bills earlier than depreciation, amortization and stock-based compensation bills for the three months ended June 30, 2023 totaled $1.1 million in comparison with $2.3 million for the three months ended June 30, 2022. The online lower was primarily attributable to the restructuring to align our organizational and administration value construction to prioritize sources to GTX-104 and scale back losses to enhance money circulation and prolong accessible money sources.

• Basic and administrative bills totaled $1.7 million earlier than stock-based compensation and depreciation expense for the three months ended June 30, 2023, a rise of $0.1 million from $1.6 million for the three months ended June 30, 2022. The rise was primarily a results of a rise in authorized, tax, accounting and different skilled charges.

• Restructuring value for the three months ended June 30, 2023, totaled $1.5 million primarily consisting of worker severance prices. On Might 8, 2023, the Firm communicated its resolution to terminate a considerable quantity of its workforce as a part of a plan that meant to align the Firm’s organizational and administration value construction to prioritize sources to GTX-104 and scale back losses to enhance money circulation and prolong accessible money sources.

• Money and money equivalents as of June 30, 2023, totaled $21.6 million, a lower of $6.2 million in comparison with money and money equivalents totaling $27.8 million at March 31, 2023, primarily on account of ongoing analysis and growth actions, and funding the restructuring expense.

• As of June 30, 2023, the Firm had 7,435,533 frequent shares issued and excellent.

About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the floor of the mind within the subarachnoid area between the mind and the cranium, which incorporates blood vessels that offer the mind. A main reason behind such bleeding is the rupture of an aneurysm. Roughly 70% of aSAH sufferers expertise loss of life or dependence, and greater than 30% die inside one month of hemorrhage. Roughly 50,000 sufferers in the US are affected by aSAH per 12 months, primarily based on market analysis.

About GTX-104

GTX-104 is a scientific stage, novel, injectable formulation of nimodipine being developed for intravenous infusion (IV) in aSAH sufferers to handle vital unmet medical wants. The distinctive nanoparticle expertise of GTX-104 facilitates aqueous formulation of insoluble nimodipine for the standard peripheral IV infusion.

GTX-104 supplies a handy IV supply of nimodipine within the Intensive Care Unit probably eliminating the necessity for nasogastric tube administration in unconscious or dysphagic sufferers. Intravenous supply of GTX-104 additionally has the potential to decrease meals results, drug-to-drug interactions, and remove potential dosing errors. Additional, GTX-104 has the potential to raised handle hypotension in aSAH sufferers. GTX-104 has been administered in over 150 wholesome volunteers and was properly tolerated with considerably decrease inter- and intra-subject pharmacokinetic variability in comparison with oral nimodipine. The addressable market in the US for GTX-104 is estimated to be about $300 million, primarily based on market analysis.

About Acasti

Acasti is a late-stage biopharma firm with drug candidates addressing uncommon and orphan illnesses. Acasti’s novel drug supply applied sciences have the potential to enhance the efficiency of presently marketed medication by reaching sooner onset of motion, enhanced efficacy, decreased unwanted side effects, and extra handy drug supply. Acasti’s lead scientific belongings have every been granted Orphan Drug Designation by the FDA, which supplies seven years of selling exclusivity post-launch in the US, and extra mental property safety with over 40 granted and pending patents. Acasti’s lead scientific asset, GTX-104, is an intravenous infusion focusing on aneurysmal Subarachnoid Hemorrhage (aSAH), a uncommon and life-threatening medical emergency by which bleeding happens over the floor of the mind within the subarachnoid area between the mind and cranium.

For extra info, please go to: https://www.acastipharma.com/en.

Ahead-Wanting Statements

Statements on this press launch that aren’t statements of historic or present reality represent “forward-looking statements” throughout the which means of the U.S. Personal Securities Litigation Reform Act of 1995, as amended, Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Change Act of 1934, as amended, and “forward-looking info” throughout the which means of Canadian securities legal guidelines (collectively, “forward-looking statements”). Such ahead wanting statements contain identified and unknown dangers, uncertainties, and different elements that would trigger the precise outcomes of Acasti to be materially totally different from historic outcomes or from any future outcomes expressed or implied by such forward-looking statements. Along with statements which explicitly describe such dangers and uncertainties, readers are urged to contemplate statements containing the phrases “believes,” “perception,” “expects,” “intends,” “anticipates,” “estimates”, “potential,” “ought to,” “might,” “will,” “plans,” “proceed”, “focused” or different related expressions to be unsure and forward-looking. Readers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date of this press launch. The forward-looking statements on this press launch, together with statements concerning the Firm’s anticipated money runway, the anticipated advantages of the Firm’s operational restructuring, the timing of the deliberate initiation of the Firm’s STRIVE-ON trial, anticipated NDA submission with the FDA, GTX-104’s potential to carry enhanced remedy choices to sufferers affected by aSAH, and the anticipated trial design of STRIVE-ON are primarily based upon Acasti’s present expectations and contain assumptions which will by no means materialize or might show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of numerous dangers and uncertainties, together with, with out limitation: (i) the success and timing of regulatory submissions of the deliberate Section 3 security research for GTX-104; (ii) regulatory necessities or developments and the end result and timing of the proposed IND utility for GTX-104; (iii) adjustments to scientific trial designs and regulatory pathways; (iv) legislative, regulatory, political and financial developments; and (v) precise prices related to Acasti’s scientific trials as in comparison with administration’s present expectations. The foregoing checklist of essential elements that would trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and ought to be learn together with statements which can be included herein and elsewhere, together with the chance elements detailed in paperwork which have been and are filed by Acasti once in a while with the Securities and Change Fee and Canadian securities regulators. All forward-looking statements contained on this press launch converse solely as of the date on which they had been made. Acasti undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made, besides as required by relevant securities legal guidelines. NASDAQ doesn’t settle for accountability for the adequacy or accuracy of this launch.

For extra info, please contact:

Acasti Contact:

Prashant Kohli
Chief Government Officer
Tel: 450-686-4555
E-mail:[email protected]
www.acasti.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Cellphone: 617-308-4306
E-mail: [email protected]

—tables to follow—

ACASTI PHARMA INC.
Condensed Consolidated Interim Statements of Loss and Complete Loss
(Unaudited)

See accompanying notes to unaudited interim monetary statements

ACASTI PHARMA INC.
Condensed Consolidated Interim Steadiness Sheet
(Unaudited)

See accompanying notes to unaudited interim monetary statements.